Systems and methods for a trial stage and/or long-term treatment of disorders of the body using neurostimulation

Abstract

Systems and methods screen and/or treat disorders of the body using neurostimulation. A trial system implants a temporary or permanent percutaneous lead and couples the lead to an external pulse generator. The external pulse generator supplies a prescribed stimulation regime through the lead to a targeted tissue region. If an improvement in the treated disorder is achieved, use of the trial system may be continued, or an implantable system may be implanted.

1 . A method for screening and/or treating a pelvic region disorder comprising
 providing an external pulse generator,   providing a percutaneous lead including a connector at or near a proximal portion, and an electrode at or near a distal portion, the electrode being electrically coupled to the connector,   inserting the distal portion of the percutaneous lead into tissue near-midline over the pubic symphysis, positioning the electrode at a target site between the pubic symphysis and the clitoris of a female or the base of the penis of a male,   coupling the percutaneous lead to the external pulse generator, and   operating the external pulse generator to convey stimulation waveforms to the electrode to screen and/or treat the pelvic region disorder.   
     
     
         2 . A method according to  claim 1   wherein the target site between the pubic symphysis and the clitoris of a female or the base of the penis of a male comprises an adipose tissue region innervated with one or more nerves.   
     
     
         3 . A method according to  claim 1   wherein the stimulation waveforms conveyed to the electrode affect stimulation of the left or right branches of the dorsal genital nerves.   
     
     
         4 . A method according to  claim 1   wherein the stimulation waveforms conveyed to the electrode affect bilateral stimulation of the left and right branches of the dorsal genital nerves.   
     
     
         5 . A method according to  claim 1   wherein the pelvic region disorder is selected from the group consisting of urinary incontinence, overactive bladder, neurogenic bladder, micturition disorders, defecation disorders, sexual disorders, prostate disorders, pelvic floor muscle disorders, and pelvic pain.   
     
     
         6 . A method according to  claim 1   wherein the step of providing an external pulse generator comprises providing a removable and replaceable carrier adapted to be worn by a user, and   providing a removable and replaceable electronics pod to electrically couple to the carrier, the electronics pod comprising circuitry adapted to generate electrical stimulation current patterns to be delivered through the percutaneous lead and to the electrode, the electronics pod also comprising a power input bay adapted to receive a self-contained, limited life, disposable, smart power source that can be released and replaced for a prescription period, the power source including circuitry to provide power source information to the electronics pod and/or receive power source information from the electronics pod.   
     
     
         7 . A method for screening and/or treating a pelvic region disorder comprising
 providing an external pulse generator,   providing a percutaneous lead including a proximal portion, and an electrode at or near a distal portion,   providing a test stimulator, the test stimulator comprising a hand-held, single use, sterile, and disposable device including test stimulation generating circuitry and a non-rechargeable and non-replaceable battery adapted to keep the test stimulator operational for a predetermined time,   implanting the distal portion of the percutaneous lead near-midline over the pubic symphysis to position the electrode at a target site between the pubic symphysis and the clitoris of a female or the base of the penis of a male,   coupling the test stimulator to the proximal portion of the percutaneous lead,   operating the test stimulator to deliver test stimulation to the electrode to confirm the electrode is positioned at the target site,   adjusting the position of the electrode if necessary to confirm the electrode is positioned at the target site,   after confirming that the electrode is positioned at the target site, uncoupling the test stimulator from the percutaneous lead,   coupling the percutaneous lead to the external pulse generator,   operating the external pulse generator to convey stimulation waveforms through the lead to the electrode to screen and/or treat the pelvic region disorder, and discarding the test stimulator.   
     
     
         8 . A method according to  claim 7   wherein the stimulation waveforms conveyed to the electrode affect stimulation of the left and/or right branches of the dorsal genital nerves.   
     
     
         9 . A method according to  claim 7   wherein the pelvic region disorder is selected from the group consisting of urinary incontinence, overactive bladder, neurogenic bladder, micturition disorders, defecation disorders, sexual disorders, prostate disorders, pelvic floor muscle disorders, and pelvic pain.   
     
     
         10 . A method according to  claim 7   wherein the implanting step is performed without fluoroscopy.   
     
     
         11 . A method for providing neurostimulation to tissue comprising:
 providing a percutaneous lead including a proximal portion and a distal portion, the distal portion including one or more electrodes,   providing an external pulse generator adapted to electrically couple to the percutaneous lead and one or more electrodes, the external pulse generator comprising a carrier adapted to be worn by a user,   providing a removable and replaceable electronics pod to electrically coupled to the carrier, the electronics pod comprising circuitry adapted to generate electrical stimulation current patterns to be delivered through the percutaneous lead and to the at least one electrode to stimulate tissue, the electronics pod also comprising a power input bay adapted to receive a self-contained, limited life, disposable, smart power source that can be released and replaced for a prescription period, the power source including circuitry to provide power source information to the electronics pod and/or receive power source information from the electronics pod,   providing instructions for use prescribing the release and replacement of the power source according to a prescribed power source replacement regime, the prescribed power source replacement regime comprising the replacement of the power source on a prescribed repeated basis similar to administering a pill under a prescribed pill-based medication regime,   providing a supply of power sources, each power source comprising a dose of power for the circuitry for administration according to the prescribed power source replacement regime,   implanting the distal portion of the percutaneous lead on, in, or near a targeted tissue region, coupling the percutaneous lead to the external pulse generator,   inserting a power source into the power input bay, the power source circuitry providing power source information to the electronics pod and/or receiving power source information from the electronics pod, and   operating the external pulse generator to convey stimulation waveforms to the targeted tissue region to provide neurostimulation.   
     
     
         12 . A method according to  claim 11   wherein the targeted tissue region comprises the left and/or right branches of the dorsal genital nerves, the pudendal nerve and/or its branches, the perineal nerves, and/or its branches, the urethral nerves, and/or its branches, and/or the sacral nerves.   
     
     
         13 . A method according to  claim 11   wherein the power source information comprises the power capacity of the power source, or the total power usage provided to date by the power source, or the total power capacity remaining in the power source, or a unique identification to identify the power source, or any combination.   
     
     
         14 . A method according to  claim 11   wherein the supply of power sources comprises the supply of power sources and a power source organizer that includes a compartment for each prescribed repeated basis, the compartment adapted to hold one or more power sources.   
     
     
         15 . A method according to  claim 11   wherein the external pulse generator provides stimulus waveforms to screen and/or treat indications, the indications selected from the group consisting of pelvic region disorders, deep brain stimulation, pain management, vagal nerve stimulation, obstructive sleep apnea, fertility, gastric stimulation, cardiac dysfunctions, functional restorations indications, and veterinary indications.   
     
     
         16 . A neurostimulation system for screening and/or treatment of pelvic region disorders comprising:
 a percutaneous lead including a proximal portion and a distal portion, the proximal portion including a connector, the distal portion able to reside in adipose tissue and including an electrode, the electrode being electrically coupled to the connector,   an external pulse generator adapted to electrically couple to the percutaneous lead, the external pulse generator comprising a removable and replaceable carrier adapted to be worn by a user, the carrier including a tissue facing surface having pressure sensitive adhesive to removably secure the carrier to the user's skin, a removable and replaceable electronics pod electrically coupled to the carrier, the electronics pod containing circuitry and adapted to generate electrical stimulation current patterns to be delivered through the percutaneous lead and to the electrode to stimulate tissue, and   a power input bay adapted to receive a self-contained, limited life, disposable, smart power source that can be released and replaced for a prescription period, the power source including circuitry to provide power source information to the electronics pod and/or receive power source information from the electronics pod.   
     
     
         17 . A system according to  claim 16   wherein the power source circuitry comprises a non-volatile memory to store the power source information.   
     
     
         18 . A system according to  claim 16   wherein the supply of power sources comprises a power source organizer that includes a compartment for each prescription period, the compartment adapted to hold one or more power sources.   
     
     
         19 . A system according to  claim 16   wherein the tissue facing surface includes a return electrode to couple to the user's skin.   
     
     
         20 . A system according to  claim 16   wherein the pelvic region disorder is selected from the group consisting of urinary incontinence, overactive bladder, neurogenic bladder, micturition disorders, defecation disorders, sexual disorders, prostate disorders, pelvic floor muscle disorders, and pelvic pain.   
     
     
         21 . A kit of devices to screen and/or treat a pelvic region disorder comprising:
 a percutaneous lead including a proximal portion, and an electrode at or near a distal portion,   an external pulse generator comprising a carrier adapted to be worn by a user and a removable and replaceable electronics pod adapted to be coupled to the carrier, the electronics pod containing circuitry and adapted to generate electrical stimulation current patterns to be delivered through the percutaneous lead and to the electrode to stimulate tissue, the electronics pod including a power input bay adapted to receive a self-contained, limited life, disposable, smart power source that can be released and replaced for a prescription period, the power source including circuitry to provide power source information to the electronics pod and/or receive power source information from the electronics pod,   one or more power sources, each power source comprising a dose of power for the circuitry for administration according to a prescribed power source replacement regime,   instructions for use prescribing the release and replacement of the power source according to the prescribed power source replacement regime, the prescribed power source replacement regime comprising the replacement of the power source on a prescribed repeated basis similar to administering a pill under a prescribed pill-based medication regime, and   instructions for implanting the electrode in tissue in a region at or near a pubic symphysis, coupling the lead to the external pulse generator, and stimulating the left and/or right branches of the dorsal genital nerves by conveying electrical stimulation waveforms from the external pulse generator to the electrode to screen and/or treat the pelvic region disorder.   
     
     
         22 . A kit according to  claim 21   wherein the power source information comprises the power capacity of the power source, or the total power usage provided to date by the power source, or the total power capacity remaining in the power source, or a unique identification to identify the power source, or any combination.   
     
     
         23 . A kit according to  claim 21   further including a supply of power sources, the supply of power sources comprises a power source organizer that includes a compartment for each prescribed repeated basis, the compartment adapted to hold one or more power sources.   
     
     
         24 . A kit according to  claim 21   wherein the electrical connection region on the electronics pod electrically couples to the mating electrical connection region on the carrier to electrically couple the circuitry on the electronics pod to a return electrode positioned on the tissue facing surface of the carrier.   
     
     
         25 . A kit according to  claim 21   wherein the system includes a patch return electrode to couple to the electronics pod.